Hull York Medical School, Institute of Clinical and Applied Health Research, Faculty of Health Sciences, University of Hull, Hull, UK.
Department of Palliative Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
BJS Open. 2022 Nov 2;6(6). doi: 10.1093/bjsopen/zrac137.
Undertaking randomized clinical trials (RCTs) in emergency surgical settings is associated with methodological and practical challenges. This study explored patients' and clinicians' perspectives associated with the conduct of an RCT comparing laparoscopic and open colorectal surgery in the acute setting.
All eligible patients screened and enrolled for the 'Laparoscopic versus open colorectal surgery in the acute setting (LaCeS)' multicentre, randomized clinical feasibility trial in five UK NHS Trusts were invited to respond to a survey. Patients and healthcare professionals were also invited to take part in semi-structured interviews. Survey and interviews explored the acceptability of the feasibility trial. Interviews were audio recorded, transcribed verbatim, and analysed using thematic analysis. Survey data were analysed descriptively to assess patient views of the trial and intervention.
Out of 72 patients enrolled for the LaCeS RCT, survey data were collected from 28 patients (38.9 per cent), and interviews were conducted with 16 patients and 14 healthcare professionals. Thirteen out of 28 patients (46 per cent) had treatment preferences but these were not strong enough to deter participation. Twelve of the patients interviewed believed that their surgeon preferred laparoscopic surgery, but this did not deter them from participating in the trial. Half of the surgeons interviewed expressed the view that laparoscopic surgery was of benefit in this setting, but recognized that the need for research evidence outweighed their personal treatment preferences. Eight of the 14 recruiters reported that the emergency setting affected recruitment, especially in centres with fewer recruiting surgeons. Interviewees reported that recruitment was helped significantly by using surgical trainees to consent patients.
This study identified specific challenges for the LaCeS trial design to address and adds significant insights to our understanding of recruiting to emergency surgical trials more broadly.
在急诊外科环境中进行随机临床试验（RCT）与方法学和实际挑战有关。本研究探讨了与在急性环境中比较腹腔镜和开放结直肠手术的 RCT 相关的患者和临床医生的观点。
所有符合条件的在英国五家 NHS 信托基金参加“腹腔镜与开放结直肠手术在急性环境中（LaCeS）”多中心、随机临床可行性试验的筛选和入组患者均被邀请回答一项调查。还邀请了患者和医疗保健专业人员参加半结构化访谈。调查和访谈探讨了可行性试验的可接受性。访谈进行了录音、逐字记录，并使用主题分析进行了分析。对调查数据进行了描述性分析，以评估患者对试验和干预的看法。
在参加 LaCeS RCT 的 72 名患者中，从 28 名患者（38.9%）中收集了调查数据，并对 16 名患者和 14 名医疗保健专业人员进行了访谈。28 名患者中有 13 名（46%）有治疗偏好，但不足以阻止他们参与试验。接受访谈的 12 名患者认为他们的外科医生更喜欢腹腔镜手术，但这并没有阻止他们参与试验。接受访谈的外科医生中有一半表示腹腔镜手术在这种情况下是有益的，但他们认识到研究证据的需求超过了他们的个人治疗偏好。14 名招募者中有 8 名报告说紧急情况影响了招募，尤其是在招募外科医生较少的中心。受访者报告说，使用外科住院医师来同意患者可以极大地帮助招募。
本研究确定了 LaCeS 试验设计需要解决的具体挑战，并为我们更广泛地了解招募急诊外科试验增加了重要的见解。
